An interventional study of IMB stress self-management health education in Psychological Stress and Nursing Students, sponsored by Changzhi Medical College. Status unknown. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Changzhi Medical College · Not applicable, Interventional, and Prevention
The aim of this cluster randomized controlled study is to test the effectiveness of IMB stress self-management health education on nursing students registered in first semester. The main question aims to answer are: Does IMB stress self-management health education program improving stress in nursing students? Researcher will compare wait-list group without any intervention to experimental group which received IMB stress self-management health education, to see if IMB stress self-management health education works to improving stress among nursing students.
Participants will Attend IMB stress self-management health education program once a week for 8 weeks. In addition, complete questionnaires at pre-intervention, post-intervention, 1-month post-intervention, 3-months post-intervention, 6-months post-intervention.
This study intends to select first-year undergraduate nursing students registered in October 2024 at Changzhi Medical College in Shanxi as the sampling population. A total of 120 eligible individual samples in eligible clusters will be screened according to inclusion and exclusion criteria, and the cluster samples will be randomly assigned to either the wait-list group or the intervention group. Participants in wait-list group will not receive any intervention, while participants in intervention group will receive IMB-based stress self-management health education. The intervention will last for 8 weeks, with one module delivers by weeks. Each module will include a 30-40 minute lecture combined with exercises, discussions, and role-playing activities. Measurements will be taken before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. These measurements will include the Stress Knowledge Questionnaire, the Multidimensional Scale of Perceived Social Support, the Self-Compassion Scale, the Resilience Scale, and the stress sub-scale of the Depression Anxiety Stress Scale.
The study data will be analyzed using the intention-to-treat (ITT) method. Continuous data will be described using mean (standard deviation) or median (interquartile range), and categorical data will be described using frequency and percentage. Repeated measures ANOVA will be used to compare differences between the two groups before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. Generalized linear models (GMM) will be utilized to determine the effects of IMB-based stress self-management health education on the variables immediately post-intervention, and at 1 month, 3 months, and 6 months post-intervention, while controlling for confounding variables. Sensitivity analysis will be performed and reported. The mean estimates will be set with a 95% confidence interval, and the significance level will be set at P \< 0.05.
This study aims to explore new low-cost approaches for current college student mental health education, improve stress self-management abilities and stress levels among nursing students, prevent mental disorders, and promote mental health. To ensure the safety of participants throughout the study, the research team will strictly adhere to ethical standards and undergo review and supervision by the ethics committee. Informed consent will be obtained from participants, and their privacy and personal information will be kept confidential, not disclosed or misused. Regular safety monitoring and risk assessments will be conducted. The research protocol will be strictly followed, and psychological counseling services will be provided to participants.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's planned enrollment of 120 is above the median of 84 across 651 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Changzhi Medical College is the lead sponsor of 3 studies on the registry; none are open to participants now.
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cluster
individual
Exclusion Criteria:
cluster
individual
participant in this group will not accept any psychological intervention content during experimental period. After the study, the intervention will be distributed for free.
Participants in this arm will receive an online "IMB stress self-management health education" program. The health education intervention program contains eight module topics.
Behavioral: IMB stress self-management health education
The health education intervention program contains eight module topics: stress-related knowledge, the thinking and mentality under stress, social support, take care of your suffering, manage your difficult emotions, acceptance, embrace a better life, ending. One topic or session is delivered by weeks, each session lasting 30-40 minutes.
Also known as: "information-motivation-behavioral skills" stress self-management health education
stress sub-scale of DASS-21
The DASS-42 is a 42 item self-report scale is designed to measure the emotional states of depression, anxiety and stress. Each of the 42 questions in DASS is scored on a 4-point scale ranging from 0("Did not apply to me at all") to 3("Applied to me very much, or most of the time"). Scores for Stress is calculated by summing the scores for the 14 items: 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39. Total score of the stress subscale ranged from 0 to 42, the level of stress can be categorized five level based on total score actually measured: normal (score from 0 to 14), mild (score from 15 to 18), moderate (score from 19 to 25), Sever (score from 26 to 33), extreme sever (score from 34 above), therefore, higher score indicate higher level of stress.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Stress Knowledge Questionnaire
Stress Knowledge Questionnaire (SKQ) is used to assess people's knowledge of stress. The questionnaire is consisting of 7 questions using true/false options as answer.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Stress Mindset Measure-General
Stress Mindset Measure- General is a self-reported instrument used to measure individual's belief toward stress. It is an 8-item tool to address the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating. Each item rated in form of 5-Likert scale, ranging from 0=strongly disagree to 4=strongly agree. The item 1, 3, 5, 7 is negative items while the item 2, 4, 6, 8 is positive item. The total score is obtained by reverse scoring the four negative items and then taking the mean of all 8 items. Higher scores represent the mindset that stress is enhancing.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Multidimensional Scale of Perceived Social Support
Multidimensional Scale of Perceived Social Support (MSPSS) is a self-report measure of social support scale that emphasizes individual subjective understanding and feelings. The questionnaire is a 12-item scale which designed to assess three perceived sources of supports: family (Items 3, 4, 8, and 11), friends (Items 6, 7, 9, and 12) and significant others (Items 1, 2, 5, and 10). Each item is scored from 1 (extremely disagree) to 7 (extremely agree). Three level of support can be categorized by the mean scale score. The mean scale score ranged from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high support.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Self-Compassion Scale Short Form
The Chinese version of Self-Compassion Scale consists 12 items on five-point Likert scale (0= 'almost never' to 5= 'almost always') to record how often you behave kindly and caring toward yourself in difficult situations. It could be used to test three dimensions of self-compassion: Common Humanity, Mindfulness, and Self-Kindly. Item 2, 4, 5, 8, 11 are reverse scored item. The total score of the instrument ranged from 12 to 60, higher score indicates higher self-compassion, vice versa. The Chinese version SCS-SF exhibit high reliability and validity.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Connor-Davidson Resilience Scale
The 10-item psychological resilience scale is used to measure the ability to cope with illness, stress, failure, etc. The scale is a 5-point Likert (0= 'almost never' to 4= 'almost most') self-reported questionnaire; The total score of the scale is the sum of the response of each item, ranged from 0 to 40; Higher total score indicates higher resilience capacity.
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2024; primary completion for Jun 2025, 8 months later.
Of 444 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 8 months is below that.
Counting every sponsor, half of 456 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Changzhi Medical College